title: Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial.
abstract: OBJECTIVE
  To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh.
  
  
  METHODS
  This was a planned final analysis of women with Pelvic Organ Prolapse Quantification (POP-Q) stage 2-4 prolapse randomized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh. We evaluated anatomic, symptomatic, and combined cure rates for those with at least 3-year validated quality-of-life questionnaires and 2- or 3-year postoperative blinded POP-Q examination. Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis.
  
  
  RESULTS
  Sixty-five women were enrolled (33 mesh, 32 no mesh) before the study was prematurely halted as a result of a 15.6% mesh exposure rate. At 3 years, 51 of 65 (78%) had quality-of-life questionnaires (25 mesh, 26 no mesh) and 41 (63%) had examinations. Three participants died, three required reoperation for recurrent prolapse (all in mesh group), and eight were lost to follow-up. No differences were observed between groups at 3 years for prolapse stage or individual prolapse points. Stage improved for each group (90% and 86%) from baseline to 3 years (P<.01). Symptomatic improvement was observed with no differences in scores between groups. Cure rates did not differ between groups using a variety of definitions, and anatomic cure was lowest for the anterior compartment.
  
  
  CONCLUSIONS
  There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh.
  
  
  BACKGROUND
  Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540.
  
  
  METHODS
  : I.
authors.affiliation: Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Women and Infants' Services, MedStar Washington Hospital Center/Georgetown University School of Medicine, Washington, DC; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California; and MedStar Health Research Institute, Hyattsville, Maryland.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Gutman
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Nosti
authors.forename: Andrew I
authors.initials: AI
authors.lastname: Sokol
authors.forename: Eric R
authors.initials: ER
authors.lastname: Sokol
authors.forename: Joanna L
authors.initials: JL
authors.lastname: Peterson
authors.forename: Hong
authors.initials: H
authors.lastname: Wang
authors.forename: Cheryl B
authors.initials: CB
authors.lastname: Iglesia
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004414:Dyspareunia / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology; D019529:Sexuality; D013526:Surgical Mesh / Q000009:adverse effects*; D014481:United States / Q000453:epidemiology; D014550:Urinary Incontinence, Stress / Q000453:epidemiology